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The Auto Suture Surgical Staples are intended to be used with the currently marketed Auto Suture TA Stapler and Single Use Loading Unit (SULU), Auto Suture GIA Stapler and SULU, and Auto Suture EEA Stapler and SULU.

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The provided text is a 510(k) premarket notification for "Auto Suture Surgical Staples." It describes the intended use and materials but does not contain detailed information about specific acceptance criteria or a study proving that the device meets those criteria.

The document states:
"PERFORMANCE DATA: In vitro and in vivo testing was performed to verify that the Auto Suture* Surgical Staples can be used with the Auto Suture TA Stapler and Single Use Loading Unit (SULU), Auto Suture GIA Stapler and SULU, and Auto Suture EEA Stapler and SULU."

This is a very high-level statement indicating that testing was done, but it does not provide the specifics requested in your prompt.

Therefore, I cannot provide the requested information, such as:

1. A table of acceptance criteria and the reported device performance: The document mentions "in vitro and in vivo testing" but does not detail what specific performance metrics were measured, what the acceptance thresholds were, or the results achieved.
2. Sample sizes used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is a physical medical device, not a diagnostic algorithm requiring ground truth from experts in the typical sense.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI/diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable (not an AI device).
9. How the ground truth for the training set was established: Not applicable (not an AI device).

The document is primarily a regulatory filing confirming substantial equivalence based on the device's material composition (titanium in compliance with ISO Standard #10993-1) and general compatibility with existing staplers, rather than a detailed performance study with quantifiable acceptance criteria.

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